Palliative systemic chemotherapy with or without pressurized intraperitoneal aerosol chemotherapy with cisplatin and doxorubicin (PIPAC C/D) for gastric cancer with peritoneal metastasis: A propensity score analysis.

Abstract

380 Background: Gastric cancer (GC) with peritoneal metastasis (PM) has a dismal prognosis. Palliative systemic chemotherapy (SC), usually doublet combinations of platinum and fluoropyrimidines, is the standard of care. Pressurized IntraPeritoneal Aerosol Chemotherapy with Cisplatin and Doxorubicin (PIPAC C/D) yields promising results. Here we aimed to compare overall survival (OS) between SC + PIPAC C/D vs. SC alone in patients with PM from GC. Methods: Prospective cohort of 95 consecutive patients with PM from GC treated in palliative intent at our institution from 2010 to 2018. Of these patients, 69 received SC + PIPAC C/D („PIPAC“), 26 SC alone („control“). Choice of treatment was not dictated by medical criteria, but by (non-) availability of the single-use medical devices needed for PIPAC in Russia. All patients received doublet or triplet chemotherapy with platinum together with fluoropyrimidines or capecitabin. A Cox proportional hazard model based on propensity score (PS) was used to assess the effect of PIPAC on OS and account for confounding factors. Results: The HR adjusted for PS for PIPAC vs. control was 0.396 (CI 5- 95% = 0.224-0.700, p-value 0.001). In the simple (unadjusted) Kaplan-Meier, median survival in the control group was 7.0 months (CI: 4.51 - 9.49) and in the PIPAC group 14.0 months (CI: 11.46-16.54). In the control group, all 26 patients died after 1-25 months. In the PIPAC group, 36 of 69 patients died after 4 to 20 months. The longest observed survival time in the PIPAC group was 27 months. Significance for the log-rank test after Mantel-Cox (not adjusted) was p < 0.0001. Conclusions: Compared with SC alone, intensified chemotherapy combining PIPAC C/D and SC doubled OS. These promising results need to be confirmed in a randomized trial.

Progress in the Treatment of Peritoneal Metastatic Cancer and the Application of Therapeutic Nanoagents

“…In the final results, the estimated median survival was 49 months for the intraperitoneal cisplatin group and 41 months for the intravenous cisplatin group, and the risk of death was lower 131 In recent years, Khomiakov et al also compared the median overall survival of patients who received systemic chemotherapy plus PIPAC versus systemic chemotherapy alone in a propensity score analysis. 132 Not surprisingly, they came to similar conclusions as other previous studies, with median overall survival of 14.0 months in the group receiving systemic chemotherapy plus PIPAC and 7.0 months in the group receiving systemic chemotherapy alone. All of these clinical trials suggest that combination therapy is more effective and promising.…”

“…In 2018, Shinkai et al evaluated the safety and efficacy of intraperitoneal PTX in combination with intravenous PTX, cisplatin, and S-1 in the treatment of patients with peritoneal metastatic cancer in a prospective phase II study, and post-treatment results showed that patients had a 1-year survival rate of approximately 80%, a median survival time of 18–25 months, and minimal complications . In recent years, Khomiakov et al also compared the median overall survival of patients who received systemic chemotherapy plus PIPAC versus systemic chemotherapy alone in a propensity score analysis . Not surprisingly, they came to similar conclusions as other previous studies, with median overall survival of 14.0 months in the group receiving systemic chemotherapy plus PIPAC and 7.0 months in the group receiving systemic chemotherapy alone.…”